Quality and Regulatory Services for Medical and IVD companies

Through our +25 years of hands-on experience, we help our customers to succeed with their medical device regulatory roadmap combined with efficient and practical Quality Management System.

To ensure the safety and effectiveness of medical devices as well as to guarantee smooth market entry, the regulations and standards have to be complied throughout the device entire life cycle. This requires holistic understanding of the requirements from relevant regulations and standards. An effective and purpose-built Quality Management System is the means to implement those requirements in practice.

We provide our customers clear and concrete advice that enables them to establish an efficient medical device 

regulatory roadmap. We also create and establish practical and efficient Quality Management System.

The concrete benefits are…

… Reduced costs thanks to;
• Shorter time-to-market
• Decreased number of iterations during market approval
• Focus on key process areas

… Competitive edge thanks to;
• Shorter time for market entries
• Solid baseline for introducing new market areas
• Solid baseline for implementing design changes and new technologies

… Peace-of-mind thanks to;
• Being sure that your medical device is safe and effective
• Full readiness to an unannounced audit
• Risks being under control and mitigated

Thus, by co-creating with Innokas, our customers can ensure that all the quality, regulatory and domain specific requirements are met during each product life cycle phase. Early involvement of our Design Studio, Manufacturing Operations and QA&RA teams ensures that the right things are being done at the right time and in the right order.

“As our global footprint expands, it is very important for us to be aware of local laws and regulations. Innokas' experience in quality and regulatory matters will help us in taking all necessary aspects into consideration at an early stage."Mikko Savola
Mikko SavolaCEO, Monidor
"To be able to sell the monitor to any country VC150 has to have both medical device approval and radio device approval. Innokas acquired CE mark for European market, the 510(k)-clearance for the device for the US market as well as the required market area specific radio device approvals.”Sami Pakarinen
Sami PakarinenProduct Manager, Innokas Medical Ltd.
  “The cooperation with Innokas helps us to ensure that all the quality and regulatory requirements that the authorities have appointed to this sector, are taken into account in Optomed’s internal processes. We’ve been very satisfied with the cooperation with Innokas QA/RA team.”Jyri Leskelä
Jyri LeskeläDirector, Quality and Regulatory, Optomed
"We have been very satisfied with the cooperation with Innokas’ experienced QA/RA team. The QA/RA consulting Innokas team offered us were based on our own operation at the very practical level which we found very valuable."Manne Hannula
Manne HannulaFormer Managing Director, Otometri

Quality and Regulatory Service Offering

We’ve created well defined and structured service packages for our Quality and Regulatory services.

 

We offer our customers our support for reaching compliance throughout the whole life-cycle of their medical device – from idea, concept and research phase to design and development, to market entries and to post-market surveillance. Thus, in addition to creation of effective and practical QMS and procedures, we help our customers to ensure the safety and effectiveness of their medical device, to reach regulatory approvals for different market areas and to upkeep their product and procedures.